Genetic Frontotemporal Dementia Initiative for Neurodevelopment

NCT05779813 | Recruiting

• 1 other identifier: GENFI-NeuroDev
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This is an international multi-centre cohort study of first and second degree family members of individuals who carry Frontotemporal Dementia (FTD) mutations in MAPT, GRN or C9ORF72 repeat expansions for youths between the ages 9-17.

Conditions

Frontotemporal Dementia; Family Members

Outcome Measures

Primary Outcomes (1)

• Brain development as measured by structural and functional Magnetic Resonance Imaging

  Through study completion, an average of 2 years

Other Outcomes (2)

• Fluid biomarkers of neurodevelopment, neurodegeneration and inflammation

  Through study completion, an average of 2 years

• Resting State quantitative electroencephalogram (EEG)

  Through study completion, an average of 2 years

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Youths between the ages of 9 and 16 inclusive at time of enrollment who have a 1st or 2nd degree biological relative with genetic FTD (i.e. a known mutation in biological parent or grandparent). Parents or guardians of potential GENFI NeuroDev participants are all aware of the autosomal dominant genetic nature of FTD in their family prior to being approached for potential participation in this study.

You may qualify if:

• Written informed consent must be obtained and documented (from the participant and their substitute decision maker). This can be obtained in person or remotely.
• Youths between the ages of 9 and 16 inclusive at time of enrollment, followed until age 17.
• Youths must have a 1st or 2nd degree biological relative who has participated (past or present) in the Genetic Frontotemporal Dementia Initiative (GENFI) study or with genetic FTD (i.e. a known mutation in biological parent or grandparent).
• Parent(s)/guardian deem appropriate to participate.
• Must have a study partner who can participate as required in the protocol (provide corroborative information). Study partner must have regular contact with the participant and must be parent/guardian of this participant.
• Must have age-appropriate awareness that FTD runs in their family as determined by local PI.

You may not qualify if:

• Current structural brain abnormality affecting cognition or behaviour not thought to be possibly related to genetic FTD that would prevent completion of study assessments (such as brain tumor, stroke, hydrocephalus).
• Other concerns that participation in the study may not be in the best interest of the youth or parent, as raised by the participant's parent/guardian/primary care provider, local site PI or psychologist.
• Lack of study partner.
• For MRI: meeting any MRI incompatible criteria. Note: Participants may opt to decline MRI scans and complete the other measures.

Sponsors & Collaborators

• Western University: lead

Study Sites (1)

Western University

London, Ontario, N6A 3K7, Canada

RECRUITING

MeSH Terms

Conditions

Frontotemporal Dementia

Condition Hierarchy (Ancestors)

Frontotemporal Lobar Degeneration; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; TDP-43 Proteinopathies; Neurodegenerative Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Elizabeth Finger, MD

  Western University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristy Coleman

CONTACT

519-646-6100; cognitive.neurology@sjhc.london.on.ca

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research, Dept. of Clinical Neurological Sciences

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: March 22, 2023
• Study Start: March 31, 2023
• Primary Completion (Estimated): March 1, 2033
• Study Completion (Estimated): March 1, 2035
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)